About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Category Archives: Industry Image
There were two major healthcare stories last week. One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Mathews Burwell to … Continue reading
Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial … Continue reading
There was an interesting article this weekend in the New York Times by Robert Pear "Privacy Issue Complicates Push to Link Medical Data" regarding the goal of the incoming Obama Administration to create jobs and great security from medical error … Continue reading
No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter. The subject of the report … Continue reading
I don’t know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows. I think he may hold the record. There has … Continue reading